Qigong for Multiple Sclerosis: A Feasibility Study

Sponsor

National University of Natural Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT04585659

Collaborator

(none)

Enrollment

Location

Arms

13.4

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This feasibility study explores a community-based qigong intervention for people with multiple sclerosis (MS). The primary aim is to assess the feasibility of weekly community qigong classes for people with MS. The secondary aim is to explore the effects of qigong on balance, gait, mood, fatigue, and quality of life.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Other: Qigong	N/A

Detailed Description

Qigong, a traditional Chinese mind-body exercise, has been shown to improve balance and gait in several neurological conditions; however, community-delivered qigong has never been assessed for people with multiple sclerosis (MS). We assessed the feasibility of community qigong classes for people with MS and explored outcomes of balance, gait, and quality of life (QOL).

Twenty adults with MS were randomly assigned to 10 weeks of community qigong classes or wait-list control. Feasibility criteria included recruitment, retention, adherence, and ability to participate in qigong movements. Secondary outcome measures included physical tests of mobility, gait and balance, and participant-reported mobility, depression, anxiety, fatigue, and QOL.

Because this is a small feasibility study, the data collected are meant to be hypothesis-generating. Any clinically meaningful trends toward improvement will justify further exploration of qigong for MS in a larger clinical trial.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Qigong for Multiple Sclerosis: A Feasibility Study

Actual Study Start Date :

Feb 1, 2017

Actual Primary Completion Date :

Mar 16, 2018

Actual Study Completion Date :

Mar 16, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Qigong Intervention 60-90 minute community qigong classes, once per week plus at least 10 minutes of home practice	Other: Qigong Mind-body movement art that includes specific movements, breath exercises, stretching and meditation. Other Names: Qi-gong
No Intervention: Wait-List Control Participants asked not to do any qigong, yoga or taichi for 10 weeks. Participants have the option to cross-over to the experimental arm after 10 weeks of no intervention.

Arm

Intervention/Treatment

Experimental: Qigong Intervention

60-90 minute community qigong classes, once per week plus at least 10 minutes of home practice

Other: Qigong

Mind-body movement art that includes specific movements, breath exercises, stretching and meditation.

Other Names:

Qi-gong

No Intervention: Wait-List Control

Participants asked not to do any qigong, yoga or taichi for 10 weeks. Participants have the option to cross-over to the experimental arm after 10 weeks of no intervention.

Outcome Measures

Primary Outcome Measures

Feasibility Outcome 1: Number of participants recruited for the study [8 months]
Ability to recruit and enroll 20 participants with multiple sclerosis (MS) within 8 months.
Feasibility Outcome 2: Number of participants retained in the study [10 weeks]
Goal to retain 80 percent of participants in the trial.
Feasibility Outcome 3: Percent able to participate in qigong classes [10 weeks]
Participation based on participants' subjective report at week 1, 2, 7 phone check-ins and exit survey. Participants select from the following options: full participation, partial, a little, or none.
Feasibility Outcome 4: Percent attendance in qigong classes [10 weeks]
Class attendance measured by self-report in exit survey and tracked by qigong instructor, with the goal of 70 percent attendance in class.

Secondary Outcome Measures

Clinical Measure 1: Walking speed assessed by the Timed-25-Foot-Walk Test [Baseline and 10 weeks]
The Timed-25-Foot-Walk (T25FW) reliably measures walking ability for people with MS, and has a high test-retest reliability (intraclass correlation coefficient (ICC) of 0.99). The test is administered and rated by a trained examiner, and consists of having the participant walk a 25-foot long course as quickly as safely possible while being timed. Once the subject reaches the end-point, he/she is asked to turn around and walk back through the course, also while being timed. The score is an average of the time needed to complete each of the two trials. Lower scores indicate faster walking ability.
Clinical Measure 2: Mobility, balance and walking ability assessed by the Timed-Up-and-Go Test [Baseline and 10 weeks]
The Timed-Up-and-Go tests muscle function and mobility, predicts safe walking ability, and correlates with other mobility tests (r=0.81 correlation with Berg Balance Scale, r=-0.61 for gait speed). The test begins with the participant sitting in an armchair with his/her back resting on the back of the chair and arms resting on the arms of the chair. The participant is then asked to stand up and walk 3 m at a comfortable and safe speed, turn around, walk back and return to a seated position. The time that it takes to complete this exercise is then recorded. Lower scores indicate faster walking ability.
Clinical Measure 3: Multidirectional mobility assessed by the Four-Square-Step-Test [Baseline and 10 weeks]
The Four-Square-Step-Test is a validated measure of multi-directional mobility for MS, with high interrater (ICC=0.99) and retest reliability (ICC=0.98). The test measures a person's ability to step over objects in four directions. We created 4 3-ft boxes on the floor using colored masking tape. Participants are asked to step from the first box forward to the second, then right to square 3, back to square 4, and left to square 1, and then go back in the opposite order (4 to 3 to 2 to 1) while being timed. The participant is allowed practice this sequence before being timed. The test is repeated twice, with the best time taken as the score. Lower scores indicate greater multi-directional mobility.
Clinical Measure 4: Physical and psychological well-being assessed by the Multiple Sclerosis Impact Scale (MSIS-29) [Baseline and 10 weeks]
The Multiple Sclerosis Impact Scale (MSIS-29) is a validated core outcome measure that allows people with multiple sclerosis (MS) to self-assess the impact of MS on their physical and psychological well-being. This scale is commonly used to assess quality of life in studies of exercise and MS. The MSIS-29 was developed in 2000 as a patient-administered survey for MS, and includes 20 questions on physical impacts and 9 questions on psychological impacts of MS.55 The MSIS scales have good variability, small floor-to-ceiling effects, high internal consistency (Cronbach's alpha < 0.91), and high test-retest reliability (intraclass correlation > 0.87). Scores are adjusted to a 0 (min) to100 (max) scale. Higher scores indicate a worsening or more severe impact of MS on a person's physical and/or psychological condition.
Clinical Measure 5: Impact of multiple sclerosis on walking ability assessed by the Multiple Sclerosis Walking Scale (MSWS-12) [Baseline and 10 weeks]
The MS Walking Scale is a 12-question self-reported measure of impact of MS on walking ability. The test has good test-retest reliability (intraclass correlation > 0.78), and high internal consistency, criterion validity, and reliability (> 0.94). We included this measure to complement the physical tests on balance and gait. Scores are adjusted to a 0-100 scale. Higher scores indicate a greater impact of MS on walking ability (i.e., more difficulty walking).
Clinical Measure 6: Fatigue assessed by the Modified Fatigue Impact Scale Short Version (MFIS-5) [Baseline and 10 weeks]
The Modified Fatigue Impact Scale (MFIS) has been recommended by the ICM as a measure of energy and drive. The measure assesses physical, cognitive and psychosocial aspects of fatigue, and has a high internal consistency (Cronbach's alpha of 0.80). The 5-item version takes 2 minutes to complete, has an adequate test-retest reliability (r=0.76), and has been shown to capture meaningful changes in fatigue. Scores range from 0-20. Higher scores indicate higher levels of fatigue.
Clinical Measure 7: Health-related quality of life assessed by the Patient Reported Outcomes Measurement Information System global heath (mental and physical, v1.1) [Baseline and 10 weeks]
Patient Reported Outcomes Measurement Information System (PROMIS) are patient reported outcome surveys developed by the National Institutes for Health. The minimum raw score is 4, and maximum is 20. Raw scores are converted to standardized T-scores relative to a population mean of 50 and SD of 10 (T-scores range from 16.2 (minimum) to 67.7 (maximum) for physical measures, and 21.2-67.6 for mental). Higher T-scores represent higher levels of global health. Scores are calibrated against the general population.
Clinical Measure 8: Health-related quality of life assessed by the Patient Reported Outcomes Measurement Information System physical function (v1.2) [Baseline and 10 weeks]
Patient Reported Outcomes Measurement Information System (PROMIS) are patient reported outcome surveys developed by the National Institutes for Health. This test is a computer adaptive test. Scores are represented as standardized T-scores relative to a population mean of 50 and SD of 10, with a minimum of 15.4 and maximum of 73.3. Higher T-scores represent higher levels of physical function. Scores are calibrated against the general population.
Clinical Measure 9: Health-related quality of life assessed by the Patient Reported Outcomes Measurement Information System fatigue (v1.0) [Baseline and 10 weeks]
Patient Reported Outcomes Measurement Information System (PROMIS) are patient reported outcome surveys developed by the National Institutes for Health. This test is a computer adaptive test. Scores are represented as standardized T-scores relative to a population mean of 50 and SD of 10, with a minimum of 34.4 and maximum of 84.7. Higher T-scores represent higher levels of fatigue. Scores are calibrated against the general population.
Clinical Measure 10: Health-related quality of life assessed by the Patient Reported Outcomes Measurement Information System anxiety (v1.0) [Baseline and 10 weeks]
Patient Reported Outcomes Measurement Information System (PROMIS) are patient reported outcome surveys developed by the National Institutes for Health. This test is a computer adaptive test. Raw scores are converted to standardized T-scores relative to a population mean of 50 and SD of 10 (minimum T-score is 32.9, maximum is 84.9). Higher T-scores represent higher levels of anxiety. Scores are calibrated against the general population.
Clinical Measure 11: Health-related quality of life assessed by the Patient Reported Outcomes Measurement Information System depression (v1.0) [Baseline and 10 weeks]
Patient Reported Outcomes Measurement Information System (PROMIS) are patient reported outcome surveys developed by the National Institutes for Health. This test is a computer adaptive test. Scores are represented as standardized T-scores relative to a population mean of 50 and SD of 10 (minimum T-score is 34.2, maximum is 84.4). Higher T-scores represent higher levels of depression. Scores are calibrated against the general population.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Living in the Portland Metropolitan Area
Self-reported diagnosis of multiple sclerosis (MS - any type)
Demonstrated ability to walk 50 feet without assistance
Stable on disease-modifying or balance medications three months prior to baseline

Exclusion Criteria:

Pregnant or nursing
Participated in qigong, tai chi, or yoga (>1 month) within six months prior to baseline
Had an MS relapse within 30 days prior to baseline.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National University of Natural Medicine, Helfgott Research Institute	Portland	Oregon	United States	97201

Sponsors and Collaborators

National University of Natural Medicine

Investigators

Principal Investigator: Angela Senders, ND, MCR, Research Investigator and Assistant Professor

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Responsible Party:

National University of Natural Medicine

ClinicalTrials.gov Identifier:

NCT04585659

Other Study ID Numbers:

102015

First Posted:

Oct 14, 2020

Last Update Posted:

Oct 14, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by National University of Natural Medicine

Additional relevant MeSH terms:

Multiple Sclerosis

Sclerosis

Study Results

No Results Posted as of Oct 14, 2020